Gunther Tulip Vena Cava Filter Set, Cook Celect Platinum Vena Cava Filter Set (2019-03-04)
- Starting date:
- March 4, 2019
- Posting date:
- March 15, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69306
Affected Products
- Gunther Tulip Vena Cava Filter Set
- Cook Celect Platinum Vena Cava Filter Set
- IGTCFS-65-1-FEM-TULIP
- IGTCFS-65-1-JUG-TULIP
- IGTCFS-65-1-UNI-TULIP
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK
- IGTCFS-65-1-FEM-CELECT-PT
- IGTCFS-65-1-JUG-CELECT-PT
- IGTCFS-65-1-UNI-CELECT-PT
- Manufacturer
-
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK
Reason
A Field Safety Notice is being launched to ensure affected customers are aware of the new version of the Inferior Vena Cava (IVC) Filter IFUs. The changes impact the device labels and the following sections of the IFUs: Device Description, Intended Use, Contraindications, Warnings, Precautions, MRI Safety Information, Potential Adverse Events, Clinical Studies, step-by-step Instructions for Use, and References.
Affected products
A. Gunther Tulip Vena Cava Filter Set
Lot or serial number
All lots.
Model or catalog number
Companies
B. Cook Celect Platinum Vena Cava Filter Set
Lot or serial number
All lots.